Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.MediciNova has presented results from its phase II/III clinical trial showing its new cystitis drug has failed to reach the primary goal of the study.
Subscribe to our email newsletter
The drug, MN-001, was well-tolerated but did not show a statistically significant clinical benefit compared to placebo on the primary endpoint at the doses tested in this trial.
Results indicated that cystitis patients were more than twice as likely to respond on 500mg of MN-001 administered twice a day compared to placebo after for weeks of treatment. This difference, however, was not observed at eight weeks due to continued improvement among placebo-treated patients. The response rate of patients treated with 500mg of MN-001 once a day did not significantly differ from placebo at either four or eight weeks.
However, MediciNova said it would continue the development of the trial as the drug had shown promise for bronchial asthma where positive clinical trial results have been observed at higher doses.
In a phase II asthma trial of MN-001, a statistically significant improvement in mean forced expiratory volume in one second was observed after four weeks of treatment with 500 mg MN-001 three times a day compared to placebo. MediciNova reported that a similar trend was observed for the 750mg twice a day dose.